Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT06001502
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-01', 'size': 520838, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-30T07:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2023-08-14', 'studyFirstSubmitQcDate': '2023-08-14', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Rating Scale (NRS)', 'timeFrame': 'Post-operative days 1,2 and 3 directly after the VR intervention', 'description': 'The NRS score is a numeric scale in which individuals rate pain from 0 (no pain) tot 10 (worst pain). This is a subjective score which is assessed verbally and used frequently in standard clinical care in multiple medical specialties.'}, {'measure': 'State- Trait Anxiety Inventory 6 questionnaire', 'timeFrame': 'Post-operative days 1,2 and 3 directly after the VR intervention', 'description': 'The STAI-6 questionnaire is a validated psychological inventory designed to measure worry, tension and anxiety in an individual. It is a shortend version of the STAI score'}, {'measure': 'Quality of Recovery-15', 'timeFrame': 'Post-operative days 1,2 and 3 directly after the VR intervention', 'description': 'The QoR-15 questionnaire is a clinical validated instrument to measure post-operative quality of recovery.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Operative Pain', 'Post Operative Anxiety', 'Heart Surgery', 'Coronary Artery Bypass Grafting', 'Virtual Reality']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate the effect of VR on post-operative pain and anxiety management in cardiac surgery patients undergoing a coronary artery bypass grafting (CABG) procedure.\n\nParticipants in the intervention group will receive a 20 minute session with the head mounted VR device on post-operative days 1,2 and 3.\n\nParticipants in the control group will be treated with conventional post-operative care.', 'detailedDescription': 'Objective: The objective of this study is to investigate the effect of VR on post-operative pain and anxiety management in cardiac surgery patients undergoing a coronary artery bypass grafting (CABG) procedure.\n\nStudy design: This study is a single-center randomized control trial.\n\nStudy population: Patients who have undergone a CABG procedure (n=100).\n\nIntervention: The intervention group (n=50) will use the VR distraction therapy device at day 1, 2 and 3 after surgery on the general ward. The control group (n=50) will be treated with conventional post-operative pain and anxiety management.\n\nMain study parameters/endpoints: The main study parameters at day 1, 2 and 3 after surgery. These are the Numeric Rating Scale (NRS) to assess the effect of pain on mobility, the Quality of Recovery-15 questionnaire, the State-Trait Anxiety Inventory-6 questionnaire and assessment of analgesic use. At follow-up, participants will be called to gather one-time QoR-15 and STAI-6 questionnaire data 6 weeks after the surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years or older with written informed consent\n* Patients undergoing surgical CABG\n\nExclusion Criteria:\n\n* Major comorbidities besides coronary artery disease\n* Complicated surgical procedure\n* Hearing and/or visual impairments\n* Psychiatric impairments\n* Complaints of vomiting and nausea\n* History of epilepsy\n* Claustrophobia\n* Facial wounds and skin defects at site of application\n* Patients placed in clinical isolation\n* Readmission to the intensive care unit'}, 'identificationModule': {'nctId': 'NCT06001502', 'acronym': 'VRECOVERY', 'briefTitle': 'The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.', 'orgStudyIdInfo': {'id': 'NL79616.018.21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality group', 'description': 'Virtual Reality distraction therapy on post-operative days 1,2 and 3.', 'interventionNames': ['Device: Virtual Reality distraction therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Conventional post-operative pain and anxiety management'}], 'interventions': [{'name': 'Virtual Reality distraction therapy', 'type': 'DEVICE', 'otherNames': ['Healthy Mind VR device'], 'description': 'The VR device simulates a 3-dimensional virtual enviroment, seeking to immerse the user in virtual surroundings', 'armGroupLabels': ['Virtual Reality group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105 AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Sulayman El Mathari, MD', 'role': 'CONTACT', 'email': 's.elmathari@amsterdamumc.nl', 'phone': '+31 205668188'}], 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Sulayman El Mathari, MD', 'role': 'CONTACT', 'email': 's.elmathari@amsterdamumc.nl', 'phone': '+31205668188'}], 'overallOfficials': [{'name': 'Jolanda Kluin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After publication', 'ipdSharing': 'YES', 'description': 'Upon request available.', 'accessCriteria': 'Upon request available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor dr. J. Kluin, MD, PhD', 'investigatorFullName': 'Jolanda Kluin', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}